MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA IV CATHETER 20 G X 1.00 IN.; INTERVASCULAR CATHETER

Catalog Number 383336

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 07/11/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It has been reported that the bd saf-t-intima iv catheter 20 g x 1.00 in.Has been found experiencing five cases of leakage during use.The following has been provided by the initial reporter: it's found that prn slipped and result in blood leakage on patient during the usage of catheter leaked blood supposed to be 10 ml.(b)(6) translation: after returning to the ward at the end of the patient's surgery, it was found that the retention needle heparin cap (the needle core end) had slipped, causing the patient to shed a beach of blood, the bed unit pollution is serious.Similar situations occur 4-5 in a week.

Manufacturer Narrative

Investigation: a device history review was conducted for lot number8115961.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Unfortunately a sample could not be obtained for evaluation and testing.Without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.

Event Description

It has been reported that the bd saf-t-intima iv catheter 20 g x 1.00 in.Has been found experiencing five cases of leakage during use.The following has been provided by the initial reporter: it's found that prn slipped and result in blood leakage on patient during the usage of catheter leaked blood supposed to b 10ml.Google translation: after returning to the ward at the end of the patient's surgery, it was found that the retention needle heparin cap (the needle core end) had slipped, causing the patient to shed a beach of blood, the bed unit pollution is serious.Similar situations occur 4-5 in a week.

• Brand Name: BD SAF-T-INTIMA IV CATHETER 20 G X 1.00 IN.
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• MDR Report Key: 8837261
• MDR Text Key: 153574632
• Report Number: 9610847-2019-00485
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903833369
• UDI-Public: 30382903833369
• Combination Product (y/n): N
• PMA/PMN Number: K013800
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 383336
• Device Lot Number: 8115961
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other